Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes (EyekonT1D)

May 16, 2022 updated by: Paolo Fiorina, MD, University of Milan

Abnormalities of the oculomotor system may represent an early sign of diabetic neuropathy and are currently poorly studied. The investigators designed an eye-tracking-based test to evaluate the oculomotor function in patients with type 1 diabetes.

The investigators used the SRLab -Tobii TX300 Eye tracker®, an eye-tracking device, coupled with a software that we developed to test abnormalities of the oculomotor system. The software consists in a series of screens divided in 5 classes of parameters (Resistance, Wideness, Pursuit, Velocity and Optokinetic Nystagmus [OKN]) to evaluate both smooth and saccadic movement in different directions. 40 healthy volunteers and 40 patients with long-standing type 1 diabetes will be enrolled to analyze the alterations in the oculomotor system and function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will enroll 40 healthy volunteers and 40 patients with long-standing type 1 diabetes. The aim of the study is to analyze alterations in the oculomotor system function as an early sign of diabetic neuropathy. A novel eye-tracking-based test will be employed and 5 parameters will be analyzed through the use of a computer-based test which will record timeframes of eye movements towards an object, type of eye movements, time between the first eye movement, number of visualization required to recognize the object across the screen. Each of these parameter will be employed to assess whether Resistance, Wideness, Pursuit, Velocity of eye movements and movements related to the Optokinetic Nystagmus are altered in type 1 diabetes as compared to non diabetic subjects.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20157
        • Sacco University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

N=40 patients with type 1 diabetes on insulin treatment N=40 healthy subjects

Description

Patients:

Inclusion Criteria:

  • Type 1 diabetes
  • willing to give consent

Exclusion Criteria:

  • Diabetic retinopathy and other ocular diseases
  • other endocrine disease
  • malignancy

Healthy volunteers:

Inclusion Criteria:

  • willing to give consent

Exclusion Criteria:

  • Other ocular diseases
  • Any endocrine disease
  • Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
Diagnostic test: Eye-tracking video test
An eye-tracking-based test will be administered to patients. It lasts 10 minutes. It consists in several screens passing by to identify objects at a certain time by a mouse clic or touchpad.
Long-standing T1D patients
Patients with long-standing type 1 diabetes
Diagnostic test: Eye-tracking video test
An eye-tracking-based test will be administered to patients. It lasts 10 minutes. It consists in several screens passing by to identify objects at a certain time by a mouse clic or touchpad.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with a change in eye movement test in each class Resistance, Velocity, Pursuit, Wideness and OKN measured by the eye-tracking based test
Time Frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of all parameters tested in each class changed in patients with type 1 diabetes as compared to healthy subjects. Parameters evaluated include number of visualization required to recognize a target and time (seconds), to recognize a target moving on the screen in different directions.
End of the study (when all patients have completed all sessions of the test), an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with a change in eye movement test in the Resistance class
Time Frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of parameters tested in the Resistance class changed in patients with type 1 diabetes as compared to healthy subjects. Resistance will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Resistance.
End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of patients with a change in eye movement test in the Wideness class
Time Frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of parameters tested in the Wideness class changed in patients with type 1 diabetes as compared to healthy subjects. Wideness will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Wideness.
End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of patients with a change in eye movement test in the Velocity class
Time Frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of parameters tested in the Velocity class changed in patients with type 1 diabetes as compared to healthy subjects. Velocity will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Velocity.
End of the study (when all patients have completed all sessions of the test), an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Collaborators

ASST Fatebenefratelli Sacco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EyekonT1D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will be shared under MTA agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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